Biological Markers in Patients With Follicular Lymphoma Treated on Clinical Trial SWOG-8809, SWOG-9800, or SWOG-9911

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896922
First received: May 9, 2009
Last updated: November 21, 2009
Last verified: June 2007
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is examining biological markers in patients with follicular lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.


Condition Intervention
Lymphoma
Genetic: microarray analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Assessment of MUM1 Expression, Lymphoma-Associated Macrophages, and Regulatory T-Cells in Follicular Lymphoma: Prognostic Markers in SWOG S8809 and S9800/S9911 Trials Representing Pre-and Post-Monoclonal Antibody Therapy Protocols

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells [ Designated as safety issue: No ]
  • Comparison of prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy [ Designated as safety issue: No ]

Estimated Enrollment: 349
Detailed Description:

OBJECTIVES:

  • Determine the prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells in patients with follicular lymphoma treated on clinical trials SWOG-8809, SWOG-9800, or SWOG-9911 representing pre- and post-monoclonal antibody therapy protocols.
  • Determine whether these factors have similar prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy on these clinical trials.

OUTLINE: This is a multicenter study.

Previously collected tissue samples from patients are analyzed by immunohistochemistry, gene expression profiling, and quantitative analysis for MUM1 expression, lymphoma-associated macrophages, FOXP3-positive regulatory T cells, CD68, and CD163.

PROJECTED ACCRUAL: A total of 318 samples will be accrued for this study.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of follicular lymphoma
  • Previously treated on any of the following clinical trials:

    • SWOG-8809
    • SWOG-9800
    • SWOG-9911

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896922

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: John W. Sweetenham, MD The Cleveland Clinic
  More Information

Additional Information:
Publications:
Sweetenham JW, Hsi E, Goldman B, et al.: Numbers of lymphoma associated macrophages (LAMS) and regulatory T-cells (Tregs) in follicular lymphoma (FL) patients (pts) treated with and without monoclonal antibody (MoAb)-containing therapy do not correlate with overall survival (OS): a study from the Southwest Oncology Group (SWOG). [Abstract] Blood 110 (11): A-2602, 2007.

ClinicalTrials.gov Identifier: NCT00896922     History of Changes
Other Study ID Numbers: CDR0000530630, SWOG-S8809/S9800
Study First Received: May 9, 2009
Last Updated: November 21, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 16, 2014